Completion of Three Dose Series of HPVICHATNCT01731496
The Efficacy of Reminders to Complete HPV Series
A study testing Telephone reminder and Text Message reminder in people with Completion of Three Dose Series of HPV and Improvement in Vaccine Intervals Between HPV Doses, run by University of Rochester at 3 sites in United States.
Trial summary
The human papillomavirus (HPV) vaccine is routinely recommended for both adolescent girls and boys starting at age 11, although it can be offered as young as 9 years of age. This is a 3-dose series and many adolescents do not complete it after getting the first dose. Read more about this study
- Who is it for?
- Ages 10 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Completion of Three Dose Series of HPV, Improvement in Vaccine Intervals Between HPV Doses
- What is being tested?
- Telephone reminder and Text Message reminder
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 749 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2012to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Parents of adolescents aged 10 - 17 who have had at least 1 dose of HPV
- Patients aged 18 - 21 who have had at least 1 dose of HPV
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Culver Medical Group
Rochester, New York, 14609
Highland Family Medicine
Rochester, New York, 14620
Strong Pediatric Practice
Rochester, New York, 14642
About this study
Official title: Improving Communication and Health for Adolescents With Technology - Implementation of Immunization Strategy
The human papillomavirus (HPV) vaccine is routinely recommended for both adolescent girls and boys starting at age 11, although it can be offered as young as 9 years of age. This is a 3-dose series and many adolescents do not complete it after getting the first dose. This study will study how effective it will be to send reminders to parents to schedule an appointment when their child is due for the next dose of HPV. Parents can chose whether they would like a phone call or text message reminder. This study will determine if the reminders work, and if one method is better than another (phone message vs. text message).
- Conditions
- Completion of Three Dose Series of HPV, Improvement in Vaccine Intervals Between HPV Doses
- Being tested
- Telephone reminder, Text Message reminder
- Keywords
- Human Papillomavirus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone reminderOther
One week prior to when a child is due for either their 2nd or 3rd HPV vaccine, their parent will receive a telephone reminder to call to make an appointment to receive their next dose. A total of 3 reminders will be sent.
Text Message reminderOther
One week prior to when a child is due for either their 2nd or 3rd HPV vaccine, their parent will receive a text message reminder to call to make an appointment to receive their next dose. A total of 3 reminders will be sent.
| Study group | Role | What they receive |
|---|---|---|
| Telephone reminder | Experimental | Telephone message reminder to parents of adolescents whose child is due for a 2nd or 3rd dose of HPV vaccine. Receives: Other: Telephone reminder |
| Text Message reminder | Experimental | Text message reminder to parents of adolescents whose child is due for a 2nd or 3rd dose of HPV vaccine. Receives: Other: Text Message reminder |
| Control: Telephone | No intervention | Not described |
| Control: Text Message | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
HPV completion rate
Post intervention HPV vaccination rates will be summarized by intervention group with frequencies and proportions, and will be compared between groups using chi square or Fisher's exact test as appropriate
Measured: One Year
Secondary outcomes (1)
HPV Dosing Intervals
Dosing intervals will be summarized by group with mean, median, standard deviation and will be compared between groups using a two sample t-test.
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2012 (estimated)
- Study startApr 2012
- Primary completionMay 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Completion of Three Dose Series of HPVStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 749 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Cynthia Rand, University of Rochester
- Investigators
- Cynthia Rand, MD, MPH, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01731496
- Sponsor's protocol ID
- 5K08HS017951-03
- Acronym
- ICHAT
- Status last verified
- Feb 2015
- First submitted
- 15 Nov 2012
- Last updated
- 6 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Rand CM, Vincelli P, Goldstein NPN, Blumkin A, Szilagyi PG. Effects of Phone and Text Message Reminders on Completion of the Human Papillomavirus Vaccine Series. J Adolesc Health. 2017 Jan;60(1):113-119. doi: 10.1016/j.jadohealth.2016.09.011. Epub 2016 Nov 8.
PubMed 27836533
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Communication and Health for Adolescents With Technology - Implementation of Immunization Strategy
- ClinicalTrials.gov ID
- NCT01731496
- Acronym / sponsor ID
- ICHAT / 5K08HS017951-03
- Conditions
- Completion of Three Dose Series of HPV, Improvement in Vaccine Intervals Between HPV Doses
- Keywords
- Human Papillomavirus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 749 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Apr 2012
- Primary completion
- May 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 21 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The human papillomavirus (HPV) vaccine is routinely recommended for both adolescent girls and boys starting at age 11, although it can be offered as young as 9 years of age. This is a 3-dose series and many adolescents do not complete it after getting the first dose. This study will study how effective it will be to send reminders to parents to schedule an appointment when their child is due for the next dose of HPV. Parents can chose whether they would like a phone call or text message reminder. This study will determine if the reminders work, and if one method is better than another (phone message vs. text message).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Telephone reminder | Experimental | Other: Telephone reminderTelephone message reminder to parents of adolescents whose child is due for a 2nd or 3rd dose of HPV vaccine. |
| Text Message reminder | Experimental | Other: Text Message reminderText message reminder to parents of adolescents whose child is due for a 2nd or 3rd dose of HPV vaccine. |
| Control: Telephone | No intervention | – |
| Control: Text Message | No intervention | – |
Who may qualify
- Ages
- 10 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Parents of adolescents aged 10 - 17 who have had at least 1 dose of HPV
- Patients aged 18 - 21 who have had at least 1 dose of HPV
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telephone reminderOne week prior to when a child is due for either their 2nd or 3rd HPV vaccine, their parent will receive a telephone reminder to call to make an appointment to receive their next dose. A total of 3 reminders will be sent. | Other | Telephone reminder |
| Text Message reminderOne week prior to when a child is due for either their 2nd or 3rd HPV vaccine, their parent will receive a text message reminder to call to make an appointment to receive their next dose. A total of 3 reminders will be sent. | Other | Text Message reminder |
Primary outcome
HPV completion rate
Time frame: One Year
Post intervention HPV vaccination rates will be summarized by intervention group with frequencies and proportions, and will be compared between groups using chi square or Fisher's exact test as appropriate
1 secondary outcome
HPV Dosing Intervals
Time frame: One Year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2015.
- Derived from this study: PubMed 27836533Rand CM, Vincelli P, Goldstein NPN, Blumkin A, Szilagyi PG. Effects of Phone and Text Message Reminders on Completion of the Human Papillomavirus Vaccine Series. J Adolesc Health. 2017 Jan;60(1):113-119. doi: 10.1016/j.jadohealth.2016.09.011. Epub 2016 Nov 8.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cynthia Rand, MD, MPH principal investigator
University of Rochester
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone reminder and Text Message reminder in people with Completion of Three Dose Series of HPV and Improvement in Vaccine Intervals Between HPV Doses, run by University of Rochester at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HPV completion rate (time frame: One Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01731496, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2015.